Infusion lubricated atherectomy catheter

ABSTRACT

A matter elimination catheter includes a catheter body extending from a catheter proximal portion to a catheter distal portion. The catheter body includes an infusion lumen, an aspiration lumen fluidly isolated from the infusion lumen, and a septum interposed between the infusion and aspiration lumens. A drive shaft is within the infusion lumen and is configured to provide rotation near the catheter distal portion. A guide wire lumen is within the drive shaft, and the infusion lumen, the drive shaft and the guide wire lumen are fluidly separated from the aspiration lumen with the septum. In one example, fluid bearings are formed between one or more of the catheter body and drive shaft or the drive shaft and a guide wire or guide wire liner when supplied with infusion fluid through the infusion lumen.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/822,384, filed Nov. 27, 2017, which is a continuation of U.S. patentapplication Ser. No. 14/640,110, filed Mar. 6, 2015, now U.S. Pat. No.9,855,070, which claims priority to U.S. Provisional Application No.61/951,856, filed Mar. 12, 2014, the entire disclosures of which areincorporated herein by reference.

TECHNICAL FIELD

This document pertains generally, but not by way of limitation, toatherectomy and thrombectomy systems and catheters.

BACKGROUND

Atherectomy and thrombectomy are procedures for removing plaques andthrombus from the vasculature. Plaques are more robust and anchored tothe vessel walls relative to thrombus, which has a softer consistencyand is more easily removed from the vessel.

In some examples, atherectomy catheters remove plaques from vessel wallsthrough mechanical engagement and abrasion of plaques. The mechanicalremoval of plaques generates loose particulate matter within the vesselwall that increases the risk of emboli within the blood stream.

Similarly, in some examples, thrombectomy procedures remove thrombusfrom vessel walls through mechanical systems that mechanically engageand remove thrombus, for instance by cutting of the thrombus with one ormore features at the end of a catheter. In still other examples,catheters include hydrodynamic features that generate streams ofsolution, such as saline, that engage with thrombus and hydrodynamicallyremove thrombus from the vessel walls. In yet other examples, solutionssuch as lytic medicants are delivered to thrombus within thevasculature, and the medicants breakdown the thrombus.

In some examples, atherectomy catheters include cutters coupled with adrive shaft to mechanically abrade plaques. The drive shaft extendsthrough an aspiration lumen. Effluent (infusion fluid includingentrained particulate) flows around the drive shaft during use of thecatheter including rotation of the drive shaft to accordingly rotate thecutters. In still other examples, guide wires are delivered through thedrive shaft to a distal portion of the catheter and into thevasculature. The catheter is translated through the vasculatureaccording to the track of the guide wire. Because the drive shaft iswithin the aspiration lumen the guide wire is also positioned within theaspiration lumen with the effluent during operation.

Infusion fluid is delivered through an infusion lumen extending throughthe catheter body. The aspiration lumen also extends through thecatheter body and is adjacent to the infusion lumen. The infusion fluidis delivered through the infusion lumen at an elevated pressure, forinstance from 50 to 500 psi. The elevated pressure ensures the infusionfluid is delivered under pressure to the catheter distal portion forentrainment of particulate for eventual aspiration through theaspiration lumen and/or to provide for balanced inflows and outflows, aswell as lubrication of moving components.

BRIEF SUMMARY

The disclosure is directed to several alternative designs, materials andmethods of manufacturing medical device structures and assemblies, anduses thereof.

In one example, a matter elimination catheter is disclosed. The catheterincludes a catheter body extending from a catheter proximal portion to acatheter distal portion. The catheter body includes an infusion lumen,an aspiration lumen fluidly isolated from the infusion lumen, and aseptum of the catheter body interposed between the infusion andaspiration lumens. The catheter also includes a drive shaft within theinfusion lumen and a guide wire lumen within the drive shaft. The driveshaft is configured to provide rotation near the catheter distalportion. The infusion lumen, the drive shaft and the guide wire lumenare fluidly separated from the aspiration lumen with the septum.

Additionally or alternatively, in another example, the septum spans thecatheter body from a first portion of a catheter body side wall to asecond portion of the catheter body side wall.

Additionally or alternatively, in another example, the catheter includesan outflow port near the catheter distal portion in communication withthe infusion lumen near the catheter distal portion and an inflow portnear the catheter distal portion in communication with the aspirationlumen near the catheter distal portion.

Additionally or alternatively, in another example, the catheter includesan infusion fluid source in communication with the infusion lumen andconfigured to provide a source of pressurized infusion fluid through theinfusion lumen and the outflow port; and an aspiration source incommunication with the aspiration lumen and configured to aspirate theinfusion fluid with entrained matter and/or with blood as an aspirantdilutant through the inflow port and the aspiration lumen. In anoperational mode the infusion fluid entrains matter from a vesselbetween the at least one outflow port and the inflow port, and theentrained matter and infusion fluid are delivered to the catheterproximal portion through the aspiration lumen. The infusion fluid mayalso maintain an isovolumetric treatment site so the vessel does nothave a tendency to suck down or collapse with vacuum pressure, as wellas provide lubrication to lubricate the cutter and the drive shaft,bearings, and other moving components.

Additionally or alternatively, in another example, in a pressurizedconfiguration pressure of the infusion fluid within the infusion lumenis greater than pressure of the infusion fluid with entrained matterexterior of the aspiration lumen, and the infusion fluid with entrainedmatter is directed away from the drive shaft within the infusion lumenaccording to the pressure difference.

Additionally or alternatively, in another example, the catheter includesa guide wire liner within the guide wire lumen of the drive shaft,wherein the drive shaft is rotatable relative to the guide wire liner.

Additionally or alternatively, in another example, the catheter includesone or more fluid bearings isolated from the aspiration lumen andgenerated with pressurized infusion fluid delivered through the infusionlumen.

Additionally or alternatively, in another example, the one or more fluidbearings include one or more of fluid dynamic bearings or hydrostaticbearings.

Additionally or alternatively, in another example, the catheter includesat least one shaft fluid bearing interposed between the catheter bodyand the drive shaft in the infusion lumen, and the at least one shaftfluid bearing is generated with pressurized infusion fluid deliveredthrough the infusion lumen.

Additionally or alternatively, in another example, the at least oneshaft fluid bearing extends from the catheter proximal portion to thecatheter distal portion.

Additionally or alternatively, in another example, the at least oneshaft fluid bearing extends the length of the drive shaft.

Additionally or alternatively, in another example, the catheter includesat least one guide wire fluid bearing interposed between the drive shaftand at least one of a guide wire or a guide wire liner in the guide wirelumen, wherein the at least one guide wire fluid bearing is generatedwith pressurized infusion fluid delivered through the infusion lumen andpenetrating the drive shaft.

Additionally or alternatively, in another example, the drive shaft iscoupled to at least one rotatable cutter near the catheter distalportion, and the drive shaft and the at least one rotatable cutter arerotatable relative to the catheter body.

Additionally or alternatively, in another example, the catheter includesat least one cutter fluid bearing interposed between the rotatablecutter and the catheter body, wherein the at least one cutter fluidbearing is formed between a cutter interface and a catheter bodyinterface with pressurized infusion fluid delivered from the infusionlumen.

Another example is a matter elimination catheter including a catheterbody extending from a catheter proximal portion to a catheter distalportion. The catheter body includes an infusion lumen in fluidcommunication with at least one outflow port near the catheter distalportion, an aspiration lumen isolated from the infusion lumen, and aseptum of the catheter body interposed between the infusion andaspiration lumens. The catheter also includes a drive shaft within theinfusion lumen. The drive shaft is configured to provide rotation nearthe catheter distal portion. In an infusion configuration, an infusionfluid is delivered through the infusion lumen to the at least oneoutflow port and/or along the bearings, cutters, drive shaft or otherrotatable catheter components in juxtaposition with static components.The drive shaft and a portion of the catheter body associated with theinfusion lumen are configured to provide at least one shaft fluidbearing therebetween with the infusion fluid. The at least one outflowport is configured to provide a fluid barrier with the infusion fluid toprevent ingress of infusion fluid with entrained matter into theinfusion lumen.

Additionally or alternatively, in another example, the catheter includesa manifold coupled to the catheter proximal portion. The manifoldincludes an infusion port configured to deliver infusion fluid to theinfusion lumen and a diversion sleeve extending proximally relative tothe infusion port, the drive shaft rotatably extending through thediversion sleeve.

Additionally or alternatively, in another example, in the infusionconfiguration the infusion fluid is directed distally over an exteriorperimeter of the diversion sleeve, and at a distal end of the diversionsleeve a first portion of the infusion fluid flows distally through theinfusion lumen toward the catheter distal portion and a second portionof the infusion fluid flows proximally along an interior perimeter ofthe diversion sleeve. The first and second portions are controlled bythe dimensions between an inner diameter of the diversion sleeve and anouter diameter of the drive shaft.

Additionally or alternatively, in another example, the second portion ofthe infusion fluid forms a shaft fluid bearing between the diversionsleeve and the drive shaft.

Additionally or alternatively, in another example, the catheter includesa guide wire extending through the drive shaft, wherein the firstportion of the infusion fluid forms a guide wire fluid bearing betweenthe drive shaft and the guide wire extending through the drive shaft.

Additionally or alternatively, in another example, the catheter includesa guide wire liner extending through the drive shaft, wherein the firstportion of the infusion fluid forms a guide wire fluid bearing betweenthe drive shaft and the guide wire liner extending through the driveshaft..

The above summary of some example embodiments is not intended todescribe each disclosed embodiment or every implementation of theaspects of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The aspects of the disclosure may be further understood in considerationof the following detailed description of various embodiments inconnection with the accompanying drawings, in which:

FIG. 1 is a side plan view of a proximal end region of an exemplarymatter elimination catheter in accordance with this disclosure;

FIG. 2 is a transverse cross-sectional view of the matter eliminationcatheter taken along line 2-2 of FIG. 1;

FIG. 3 is a longitudinal cross-sectional view of the proximal end regionof the exemplary matter elimination catheter of FIG. 1;

FIG. 4 is an enlarged view of a portion of the matter eliminationcatheter shown in FIG. 3;

FIG. 5 is an enlarged view of a portion of the matter eliminationcatheter shown in FIG. 4;

FIG. 6 is an enlarged view of a portion of the matter eliminationcatheter shown in FIG. 4;

FIG. 7 is an enlarged view of a portion of the matter eliminationcatheter shown in FIG. 4;

FIG. 8 is an enlarged view of a portion of the matter eliminationcatheter shown in FIG. 3;

FIG. 9 is an enlarged view of a portion of the matter eliminationcatheter shown in FIG. 8;

FIG. 10 is a side plan view of a distal end region of an exemplarymatter elimination catheter in accordance with this disclosure;

FIG. 11 is a longitudinal cross-sectional view of the distal end regionof the exemplary matter elimination catheter of FIG. 10 taken along line11-11 of FIG. 10;

FIG. 12 is a transverse cross-sectional view of the matter eliminationcatheter taken along line 12-12 of FIG. 10;

FIG. 13 is a cross-sectional view illustrating exemplary flows throughthe distal end region of the exemplary matter elimination catheter ofFIG. 11;

FIG. 14 is a side plan view of an alternative distal end region of anexemplary matter elimination catheter in accordance with thisdisclosure;

FIG. 15 is a longitudinal cross-sectional view of the distal end regionof the exemplary matter elimination catheter of FIG. 14 taken along line15-15 of FIG. 14;

FIG. 16 is a transverse cross-sectional view of the matter eliminationcatheter taken along line 16-16 of FIG. 14; and

FIG. 17 is a cross-sectional view illustrating exemplary flows throughthe distal end region of the exemplary matter elimination catheter ofFIG. 15.

While the aspects of the disclosure are amenable to variousmodifications and alternative forms, specifics thereof have been shownby way of example in the drawings and will be described in detail. Itshould be understood, however, that the intention is not to limitaspects of the disclosure to the particular embodiments described. Onthe contrary, the intention is to cover all modifications, equivalents,and alternatives falling within the spirit and scope of the disclosure.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

Definitions of certain terms are provided below and shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about”, whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (i.e., having the same function orresult). In many instances, the term “about” may be indicative asincluding numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4,and 5).

Although some suitable dimensions, ranges and/or values pertaining tovarious components, features and/or specifications are disclosed, one ofskill in the art, incited by the present disclosure, would understanddesired dimensions, ranges and/or values may deviate from thoseexpressly disclosed.

As used in this specification and the appended claims, the singularforms “a,” “an,” and “the” include or otherwise refer to singular aswell as plural referents, unless the content clearly dictates otherwise.Accordingly, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one, independent of any otherinstances or usages of “at least one” or “one or more”. As used in thisspecification and the appended claims, the term “or” is generallyemployed to include “and/or,” unless the content clearly dictatesotherwise. Accordingly, the term “or” is used to refer to a nonexclusiveor, such that “A or B” includes “A but not B,” “B but not A,” and “A andB,” unless otherwise indicated. As used in this specification and theappending claims, the terms “including” and “comprising” are open-ended,that is, a system, device, article, composition, formulation, or processthat includes elements in addition to those listed after such a term ina claim are still deemed to fall within the scope of that claim.Moreover, in the following claims, the terms “first,” “second,” and“third,” etc. are used merely as labels, and are not intended to imposenumerical requirements on their objects.

In the event of inconsistent usages between this document and anydocuments so incorporated by reference, the usage in this documentcontrols.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The detailed description and the drawings, which are notnecessarily to scale, depict illustrative embodiments and are notintended to limit the scope of the disclosure. The illustrativeembodiments depicted are intended only as exemplary. Selected featuresof any illustrative embodiment may be incorporated into an additionalembodiment unless clearly stated to the contrary.

The present inventors have recognized, among other things, that aproblem to be solved can include the fouling of the aspiration lumenwith particulate matter including fibrin, plaques and thrombus. Foulingis particularly problematic with a drive shaft in the aspiration lumenas rotation of the drive shaft may be prevented. Still further, foulingmay not prevent rotation of the drive shaft, but it may cause seizing ofa guide wire by the drive shaft with the guide wire positioned invasculature. Rotation of the seized guide wire within vasculature shouldbe avoided.

In an example, the present subject matter can provide a solution tothese and other problems, such as by isolating the drive shaft and aguide wire or guide wire liner within the drive shaft from the effluentwithin the aspiration lumen. In one example, the drive shaft and theguide wire lumen interior to the drive shaft extend through an infusionlumen that is isolated from the aspiration lumen where the effluent isdirected during operation of a catheter. A septum between the aspirationand infusion lumens isolates the drive shaft. Infusion fluid deliveredalong the infusion lumen is clean (e.g., without particulate, such asfibrin, that may cause seizing of the drive shaft) and lubricates thedrive shaft to facilitate rotation without the risk of fouling. Suitableinfusion fluids include, but are not limited to, saline. Other suitableinfusion fluids which are lubricants made for rotational atherectomydevices include Rotaglide® and Viperslide®. In certain embodiments, theinfusion includes a medicament, such as, but not limited to,anti-restenosis or anti-thrombosis medicaments. Similarly, by isolatingthe guide wire and a guide wire lumen from the effluent the seizing ofthe guide wire by the drive shaft is substantially prevented. Further,the clean infusion fluid provides a lubricant to facilitate the movementof the catheter relative to the guide wire.

Further still, the infusion fluid is delivered at an elevated pressure,for instance 50 to 500 psi (100 to 250 psi or 50 to 100 psi). Thepressurized and clean infusion fluid is delivered along the length ofthe drive shaft within the infusion lumen. The infusion fluid iseventually delivered through one or more outflow ports near a catheterdistal portion. In one example, the outflow ports are dedicated portsthat provide a cyclical flow of fluid configured to entrain looseparticulate for eventual delivery to an inflow port of the aspirationlumen. In another example, the outflow ports include virtual portsprovided between rotating features of the catheter, such as theinterfaces of the catheter body (e.g., between one or more of catheterbody material, saddle or a fitting) and the rotatable cutters. Asdescribed herein the infusion fluid provides a fluid barrier at theseoutflow ports. The outflow of infusion fluid from the outflow portsgenerates a fluid barrier that substantially prevents the ingress ofparticulate (e.g., thrombus or plaques) into the infusion lumen. In oneexample, the fluid barriers are generated by a pressure differentialbetween the infusion fluid in the infusion lumen and the effluentoutside of the infusion lumen. Accordingly, in another example, thedrive shaft and a guide wire therein are substantially protected fromfouling through a combination of the isolation of the infusion lumenfrom the aspiration lumen and the fluid barrier at each of the outflowports. Furthermore, in some instances the cutting action may be enhancedby the action of displacing particles and reducing heat friction withthe infusion fluid.

The present inventors have further recognized, among other things, thata problem to be solved can include minimization of rotational frictionbetween a rotating drive shaft of a catheter and one or more of thecatheter body and a guide wire. As described above, translational androtational friction, including seizing of a guide wire is a negativeoutcome. Accordingly, minimizing translational and rotational frictionfor both the drive shaft and the guide wire caused by one or more ofmechanical engagement of features (e.g., drive shaft to guide wire orcatheter body) or effluent including particulate is desired.

In an example, the present subject matter can provide a solution to thisproblem, such as by isolating the drive shaft and a guide wire or guidewire liner within the drive shaft from the effluent and providing a flowof clean infusion fluid that may also act as a lubricant. As describedherein, the drive shaft and guide wire lumen within the drive shaft areisolated from an aspiration lumen by placement within an infusion lumen.The pressurized flow of “clean” infusion fluid along the length of thedrive shaft and the guide wire lubricates both the drive shaft and theguide wire and facilitates translation and/or rotation of both (e.g.,relative to each other and the catheter body).

In addition to the provision of a clean lubricant, the drive shaft andthe guide wire (or guide wire lumen liner) are both subject topressurized infusion fluid that forms at least one fluid bearing (e.g.,fluid dynamic bearings or hydrostatic bearings) extending between andoptionally including moving portions of the catheter distal end, such asa rotating cutter (e.g., a one or more of a first cutter and a secondcutter); or locations where prevention of ingress of effluent isdesired. For instance, a fluid bearing of the drive shaft extends fromthe catheter proximal portion to the termination of the drive shaft nearthe catheter distal portion. The infusion fluid is positioned betweenthe drive shaft and the catheter body, and penetrates the drive shaftunder pressure to provide a fluid bearing between the drive shaftinterior and a guide wire and/or guide wire liner. The resulting atleast one fluid bearing facilitates rotation and/or translation of thedrive shaft and the guide wire even in the most tortuous of vasculature.Further, the at least one fluid bearing facilitates the easy translationof the catheter over the guide wire or the converse. Additionally, atleast one fluid bearing prevents the transmission of rotation from thedrive shaft to the guide wire and thereby minimizes rotation of theguide wire within vasculature. The fluid bearings reduce the need forprecise machining and maintenance of mechanical bearings needed withrotational features, such as cutters, in other designs.

Moreover, as described above, the high pressure infusion fluid used toinfuse and lubricate is delivered to one or more rotatable cutters nearthe catheter distal portion. The infusion fluid is directed betweeninterfaces of the cutters and the catheter body (e.g., catheter bodymaterial, fittings, or the like). The infusion fluid provides alubricant layer and fluid bearing at these interfaces to facilitate therotation of the cutters and substantially prevent the transmission ofrotation or seizing of the cutters by engagement with the catheter tube,sleeves, or the like with the cutters.

The lubrication of the interfaces between the drive shaft, the catheterbody and one or more of a guide wire or guide wire liner facilitates aminimized construction for the proximal manifold of the system includingthe infusion and aspiration ports and the motor coupled with the driveshaft. For instance, multiple speed configurations and controls for thesame can be removed as seizing of the drive shaft on the guide wire iseliminated (minimized or eliminated) in favor of reliable operation ofthe drive shaft to rotate the cutters at a desired speed. Additionally,anchoring features including, but not limited to, clamps, septums andthe like used to grasp a guide wire and prevent movement, such asrotation, of the guide wire are obviated with the isolation of the driveshaft and the guide wire in the infusion lumen and the provision of oneor more fluid bearings as provided herein. In one example, the manifoldof the system includes the infusion and aspiration ports coupled withthe corresponding infusion fluid and aspiration sources, a motor coupledwith the drive shaft (e.g., by a pinion gear), and an optionalTuohy-Borst adapter for the introduction of the guide wire to theinfusion lumen and the guide wire lumen of the drive shaft.

The optional Tuohy-Borst adapter assists in priming the guide wire lumen(e.g., within the drive shaft) in a construction using the guide wireliner (described herein). The need for rotational guide wire exchange(REX), an exchange technique using a lower rotation speed when aphysician wants to move an atherectomy catheter on a guide wire (e.g.,to prevent disturbance or damage to tissue), is eliminated with thefluid bearings as described herein. The fluid bearings provide a fluidinterface between the guide wire lumen of the drive shaft and the liner(or alternatively between the drive shaft and the guide wire if no lineris present) to accordingly facilitate the sliding exchange of a guidewire relative to the catheter. In another example, a dedicated guidewire liner is self-priming with the guide wire by penetrating an orificeat a point along the guide wire liner so high pressure fluid (e.g.,saline, lubricant, and/or medicament) bleeds through the orifice tocontinually fill the ID of the guide wire liner with saline and/orlubricant, such as Rotaglide® or Viperslide®. The orifice is optionallylocated near a distal portion of the catheter (e.g., distal to the driveshaft) to minimize risk of a structural failure of a non-rotatablefeature. In other words, any failure would occur distally of the driveshaft and accordingly not result in seizing and transmission of rotationto the guide wire.

Further still, a catheter including a septum in the catheter body thatdivides the infusion and aspiration lumens is more efficient with regardto infusion aspiration capacities because the resulting dual lumens(divided by the septum) provide additional cross sectional area for eachlumen relative to a corresponding catheter having coaxial lumens (e.g.,an infusion tube within an aspiration lumen or the converse). Additionalefficiencies are realized because movement of the higher viscosityparticulate entrained effluent (relative to just the infusion fluid) isnot resisted by rotation of the drive shaft. Instead, the effluent isisolated from the rotating drive shaft and accordingly free to movealong the catheter body without rotational resistance from the driveshaft. Similarly, the drive shaft is not slowed by passage of theeffluent including the entrained particulate. Instead, the drive shaftis bathed by the infusion fluid in the infusion lumen, and the infusionfluid has a lower viscosity and that accordingly minimizes rotationalresistance for the drive shaft. In this manner the energy supplied andconsumed by a catheter incorporating these features is conserved andoptimally used (e.g., for the provision of rotation, infusion andaspiration).

In another example, the dual lumen catheter body includes the septumspanning the catheter body. The catheter body including the septumprovides greater structural integrity provides enhanced pushability.Furthermore, the structural integrity is realized in a cost effectivefashion as the catheter body is extruded from polymer and optionallyincludes a braid, as opposed to a laser cut tube. Expensive and laborintensive inner and outer sheaths are accordingly avoided.

Furthermore, providing a dual lumen tube negates the possible pinchingeffect encountered with sheaths in existing devices which can close offinfusion fluid being delivered to the distal tip of the device, and incertain circumstances may lead to ballooning of the outer sheath andpossible burst of the weakened area.

Now referring to FIG. 1 and the associated cross-sectional view of FIG.3, there is illustrated a proximal end region of an exemplary matterelimination catheter 10. The proximal end region of the catheter 10 mayinclude a manifold 12 attached to a proximal end of an elongate shaft14, with the elongate shaft 14 extending distally therefrom.

The elongate shaft 14 may include a catheter body 16 having a proximalend extending into and secured to the manifold 12. For example, a bondregion 18 between the catheter body 16 and the manifold 12, shown inFIG. 2, may secure the catheter body 16 to the manifold 12. For example,proximal end of the catheter body 16 may be adhesively bonded, thermallybonded, mechanically coupled or otherwise secured to the manifold at thebond region 18.

The catheter body 16 may include one or more, or a plurality of lumensextending therethrough. For example, the catheter body 16 may include aninfusion lumen and an aspiration lumen fluidly isolated from theinfusion lumen, as well as one or more additional lumens, if desired. Asshown in FIG. 2, in some instances the catheter body 16 may be a duallumen extruded tubular member defining an infusion lumen 20 and anaspiration lumen 22 fluidly isolated from the infusion lumen 20. Thus,the catheter body 16 may be a monolithic structure including both aninfusion lumen 20 and an aspiration lumen 22 extending therethrough.

The catheter body 16 may include a septum 24 spanning across thecatheter body 16 to divide the interior space of the catheter body 16into infusion lumen 20 and the aspiration lumen 22. For example, theseptum 24 may span from the annular outer wall of the catheter body 16on one side of the catheter body 16 to the annular outer wall of thecatheter body 16 on an opposite side of the catheter body 16. Thus, afirst surface 26 of the septum 24 may partially define the infusionlumen 20 along with a first portion of the inner surface of the annularouter wall of the catheter body 16, while a second surface 28 of theseptum 24 may partially define the aspiration lumen 22 along with asecond portion of the inner surface of the annular outer wall of thecatheter body 16.

In some instances, as shown in FIG. 2, the septum 24 may have a bowed orarcuate configuration such that one of the first and second surfaces 26,28 of the septum 24 is convex while the other of the first and secondsurfaces 26, 28 of the septum 24 is concave. For example, the firstsurface 26 of the septum 24 may be concave such that the infusion lumen20 may have a generally elliptical or oval shape, while the secondsurface 28 of the septum 24 may be convex such that the aspiration lumen22 may have a generally crescent shape. In other embodiments, thecurvature of the septum 24 may be reversed, in which case the shapes ofthe infusion lumen 20 and the aspiration lumen 22 may also be reversed.In yet other embodiments, the septum 24 may be planar, with opposingflat surfaces.

Referring to FIGS. 4 and 5, the manifold 12 may include an infusion port32 in fluid communication with the infusion lumen 20 for delivering aninfusion fluid through the infusion lumen 20 to the distal end of theelongate shaft 14. In some instances, a first Y-adapter may provide theinfusion port 32. A source of infusion fluid may be coupled to theinfusion port 32 during operation of the catheter 10.

Referring to FIGS. 4 and 6, the manifold 12 may also include anaspiration port 34 in fluid communication with the aspiration lumen 22for withdrawing effluent through the aspiration lumen 22 from the distalend of the elongate shaft 14. For example, a proximal portion of thecatheter body 16 within the manifold 12 may be skived to provide a fluidpathway between the aspiration lumen 22 and the aspiration port 34,leaving the septum 24 and portion of the catheter body 16 defining theinfusion lumen 20 extending further proximal of the aspiration port 34.The septum 24 and portion of the catheter body 16 defining the infusionlumen 20 proximal of the aspiration port 34 may be secured to themanifold 12 at a bond location 84 proximal of the aspiration port 34 andthe aspiration lumen 22. The bond location 84 may isolate infusion fluidentering the infusion lumen 20 of the catheter body 16 through theinfusion port 32 from effluent exiting the aspiration lumen 22 of thecatheter body 16 through the aspiration port 34. In some instances, asecond Y-adapter may provide the aspiration port 34. A vacuum source maybe coupled to the aspiration port 34 during operation of the catheter 10to draw a vacuum through the aspiration lumen 22.

As shown in FIGS. 2, 3 and 4, the elongate shaft 14 may also include adrive shaft 30 extending through a lumen of the catheter body 16. Forexample, the drive shaft 30 may extend through the infusion lumen 20,and thus be isolated from the aspiration lumen 22 and effluent passingthrough the aspiration lumen 22. In some instances, the drive shaft 30,or a portion thereof, may include a coiled member formed of one or moretight wound filaments and/or a solid-walled tubular member. In someinstances, a proximal portion of the drive shaft 30 may be formed of asolid-walled tubular member 36 and a distal portion of the drive shaft30 may be formed of a coiled member 38 secured to the solid-walledtubular member 36, as shown in FIG. 6. For instance, a proximal end ofthe coiled member 38 may be secured to a distal end of the solid-walledtubular member 36 at a joint, such as a butt joint, or a lap joint(e.g., the proximal end of the coiled member 38 may extend into thelumen of the solid-walled tubular member 36, or vice versa). In someinstances, a sleeve 48 may extend across the joint, surrounding both theproximal end of the coiled member 38 and the distal end of thesolid-walled tubular member 36, and secured thereto. The sleeve 48 mayextend along any length of the coiled member 38 and/or the solid-walledtubular member 36, as desired.

The drive shaft 30 may be rotatable and/or axially translatable withinthe infusion lumen 20 of the catheter body 16. For example, the matterelimination catheter 10 may include a prime mover (not shown) to providerotational motion to the drive shaft 30 to rotate a cutting memberpositioned at the distal end of the elongate shaft 14. For example, insome instances the prime mover may be an electrical motor, a fluidturbine, or the like. A controller (not shown) may be used to controlthe prime mover. For example, the user may provide power to the primemover and/or control the speed of rotation of the drive shaft 30 via acontroller. In the illustrated embodiment, a pinion gear 46 may besecured to the drive shaft 30 to transfer rotational motion from theprime mover to the drive shaft 30. For example, the pinion gear 46 maybe secured to a pinion shaft 56, which is secured to the drive shaft 30such that rotation of the pinion gear 46 and pinion shaft 56 causesrotation of the drive shaft 30 within the catheter body 16.

In some embodiments, the lumen of the drive shaft 30 may define theguide wire lumen 42 extending through the drive shaft 30. However, inother embodiments, a guide wire liner 40 may extend through the lumen ofthe drive shaft 30 to define the guide wire lumen 42, as shown in theillustrated embodiment. The guide wire liner 40 may be a thin walledtubular member creating an interface between the inner surface of thedrive shaft 30 and the guide wire extending through the guide wire lumen42. The guide wire liner 40 may be positioned with the lumen of thedrive shaft 30 such that the guide wire liner 40 remains stationary asthe drive shaft 30 rotates during operation of the catheter 10.Accordingly, there is no relative rotational movement between the guidewire and the component directly surrounding the guide wire (e.g., theguide wire liner 40) during operation of the catheter 10. As shown inthe illustrated embodiment, the guide wire liner 40 may extend theentire length of the drive shaft 30, and may extend proximal of theproximal end of the drive shaft 30 and/or may extend distal of thedistal end of the drive shaft 30.

The drive shaft 30, such as the solid-walled tubular member 36 (e.g., astainless steel hypotube), may extend into and/or through a distal sealtube 80, shown in FIGS. 4, 6 and 7. The distal seal tube 80 may be apolymeric tubular member, such as a polyimide tubular member, in someinstances. The distal seal tube 80 may be secured to the manifold 12 ata bond location 82. Accordingly, the drive shaft 30 may be rotatablerelative to the distal seal tube 80 and the manifold 12. A tighttolerance may be maintained between the outer surface of the drive shaft30 and the inner surface of the distal seal tube 80 to provide ahydraulic seal therebetween. Thus, infusion fluid introduced through theinfusion port 32 may not escape and/or air may not enter through theclearance between the drive shaft 30 and the distal seal tube 80.

As shown in FIG. 8, the catheter 10 may also include an adapter 50, suchas a Tuohy-Borst adapter, coupled to a proximal end of the drive shaft30 and/or guide wire liner 40, if present. For instance, the proximalend of the drive shaft 30 and/or the proximal end of the guide wireliner 40 may extend into the adapter 50. As shown, the guide wire liner40 may extend proximal of the proximal end of the drive shaft 30 and besecured to the adapter 50 at a bond location 68. The adapter 50 mayinclude a guide wire port 52 providing guide wire access to the guidewire lumen 42. The adapter 50 may also include a side or auxiliaryaccess port 54 for access to the guide wire lumen 42.

The adapter 50 may include a guide wire director 76 to facilitatepositioning a guide wire into the guide wire lumen 42. For example, theguide wire director 76 may include a tapered or conical bore arranged todirect a guide wire into the guide wire lumen 42. Although not shown,the adapter 50 may include a hemostasis valve to create a fluid sealaround a guide wire inserted into the guide wire lumen 42.

Furthermore, the drive shaft 30, such as the solid-walled tubular member36, may extend into and/or through a proximal seal tube 70, shown inFIG. 9. The proximal seal tube 70 may be a polymeric tubular member,such as a polyimide tubular member, in some instances. The proximal sealtube 70 may be secured to the adapter 50 at a bond location 72.Accordingly, the drive shaft 30 may be rotatable relative to theproximal seal tube 70 and the adapter 50. A tight tolerance may bemaintained between the outer surface of the drive shaft 30 and the innersurface of the proximal seal tube 70 to provide a hydraulic sealtherebetween.

In some instances, the proximal seal tube 70, or another tubular membersurrounding the drive shaft 30, may serve as a diversion sleeve fordiverting infusion fluid distally along the drive shaft 30. The proximalseal tube 70 (or other tubular member), which may extend proximallyrelative to the infusion port 32, may extend along the drive shaft 30for a distance distal of the infusion port 32. In some instances, theproximal seal tube 70 (or other tubular member) serving as a diversionsleeve may extend along the drive shaft 30 distal of the infusion port32 any desired length, such as about 1 inch (2.54 cm) or less, about 2inches (5.08 cm) or less, about 3 inches (7.62 cm) or less, or about 4inches (10.16 cm) or less, although other lengths may also be used.Accordingly, infusion fluid introduced through the infusion port 32 maybe directed distally over an exterior perimeter of the diversion sleeve(e.g., the proximal seal tube 70) up to the distal end of the diversionsleeve, at which point a first portion of the infusion fluid flowsdistally through the infusion lumen 20 toward the distal end region ofthe catheter 10 and a second portion of the infusion fluid flowsproximally along an interior perimeter of the diversion sleeve (e.g.,the proximal seal tube 70) between the drive shaft 30 and the diversionsleeve (e.g., the proximal seal tube 70). The distribution of infusionfluid between the first and second portions may be controlled by thelength of the diversion sleeve distal of the infusion port 32 and/or thedimensions (e.g., tolerance) between the inner diameter of the diversionsleeve and the outer diameter of the drive shaft 30. The first portionof the infusion fluid may provide a fluid bearing between a guide wireor the guide wire liner 40 and the drive shaft 30, while the secondportion of infusion fluid may provide a fluid bearing between the driveshaft 30 and the diversion sleeve (e.g., the proximal seal tube 70).

In some instances, the manifold 12, including the infusion port 32 andthe aspiration port 34, may be considered a distal manifold assembly andthe adapter 50, providing the guide wire port 52, may be considered aproximal manifold assembly. The pinion gear 46 and pinion shaft 56 maybe positioned between the distal manifold assembly (e.g., manifold 12)and the proximal manifold assembly (e.g., adapter 50), and rotatablerelative to both the manifold 12 and the adapter 50.

An exemplary distal end region of the catheter 10 is illustrated atFIGS. 10 and 11. The distal end region of the catheter 10 may include arotatable cutting member 60 positioned at the distal end of the elongateshaft 14. The cutting member 60 may be secured to the distal end of thedrive shaft 30, and thus rotated through rotation of the drive shaft 30.For example, the distal end of the drive shaft 30 may extend into a boreof a proximal neck 62 of the cutting member 60 and be fixedly securedthereto, such as by welding, adhesive, interference fit, or the like.The cutting member 60 may include one or more flutes having a cuttingedge for removing occlusive material from a body lumen. In otherinstances, the cutting member 60 may be a burr having an abrasivesurface, such as a diamond coated abrasive surface, or the cuttingmember 60 may be of another construction for abrading or cuttingocclusive material. In some instances, the cutting member 60 may bepositioned distal of the catheter body 16. In other instances, thecutting member 60, or a portion thereof, may be positioned within thedistal end region of the catheter body 16, if desired.

In some instances, the cutting member 60 may be rotatably coupled to thecatheter body 16. For example, as shown in FIGS. 10 and 11, a couplingassembly may be provided at the distal end region of the elongate shaft14 to permit rotation between the cutting member 60/drive shaft 30 andthe catheter body 16. For example, the coupling assembly may include asaddle 64 at the distal end of the catheter body 16 and a retaining ring66 secured to the drive shaft 30. The saddle 64 may be an integralportion of the catheter body 16, or a separate component securedthereto. The saddle 64 may be fixedly secured to the distal end of thecatheter body 16 by welding, crimping, adhesive, interference fit, orthe lit. Similarly, the retaining ring 66 may be fixedly secured to thedrive shaft 30, such as the outer surface of the drive shaft 30, bywelding, crimping, adhesive, interference fit, or the like. The saddle64 and the retaining ring 66 may be formed of any desired material, suchas stainless steel, titanium, tungsten, or other metallic material,although polymeric or ceramic materials, as well as other materials mayalso be used if desired. The saddle 64 may be configured to constrainproximal and distal movement of the cutting member 60 relative to thecatheter body 16 while permitting rotational movement of the cuttingmember 60 relative to the catheter body 16. For example, the neckportion 62 of the cutting member 60 may extend into the saddle 64 suchthat a stop surface of the neck portion 62 engages with a stop surface(e.g., distal flange) of the saddle 64 to inhibit proximal movement ofthe cutting member 60 relative to the catheter body 16. In someinstances, the saddle 64 may serve as a guide or bearing to maintainalignment between the cutting member 60 and the catheter body 16.Furthermore, the retaining ring 66 may be fixedly secured to the driveshaft 30 proximal of the saddle 64 such that a stop surface of theretaining ring 66 engages with a stop surface (e.g., proximal flange) ofthe saddle 64 to inhibit distal movement of the drive shaft 30, and thusthe cutting member 60, relative to the catheter body 16.

The saddle 64 may be fixedly secured to the catheter body 16 in anydesired way. For example, the saddle 64 may be adhesively bonded and/ormechanically engaged to the catheter body 16. In the illustrativeembodiment, a radiopaque marker ring 58 may be crimped around a portionof the catheter body 16 overlaying a reduced diameter portion (e.g., anannular groove) of the saddle 64 to secure the catheter body 16 to thesaddle 64.

The cutting member 60 may include a distal opening 44 aligned with theguide wire lumen 42 to permit a guide wire to pass therethrough into theguide wire lumen 42. The guide wire liner 40, if present, may extendthrough the drive shaft 30 to define the guide wire lumen 42. The guidewire liner 40 may extend distal of the distal end of the drive shaft 30into the bore of the cutting member 60 to form an interface between thecutting member 60 and a guide wire extending through the guide wirelumen 42. The bore of the cutting member 60 may have a diameter slightlylarger than the outer diameter of the guide wire liner 40 to provide aclearance for infusion fluid to pass therebetween to lubricate the guidewire, as will be further discussed herein. The guide wire liner 40 mayremain stationary as the cutting member 60 is rotated. Thus, the cuttingmember 60 is rotatable relative to the guide wire liner 40 duringoperation, such that the guide wire is isolated from direct contact withthe rotating cutting member 60 except at the distal opening 44 of thecutting member 60.

The distal end region of the elongate shaft 14 may include one or more,or a plurality of aspiration or inflow ports for aspirating effluentinto the aspiration lumen 22 of the catheter body 16. For example, thedistal end region of the catheter body 16 may include an inflow port 74opening into the aspiration lumen 22. As shown in FIG. 12, the inflowport 74 may open into the aspiration lumen 22 through a sidewall of thecatheter body 16. The septum 24 may isolate the drive shaft 30,extending through the infusion lumen 20 from effluent passing into theaspiration lumen 22. Furthermore, FIG. 12 illustrates that within thedistal end region, the septum 24 may have a bowed or arcuateconfiguration such that one of the first and second surfaces 26, 28 ofthe septum 24 is convex while the other of the first and second surfaces26, 28 of the septum 24 is concave. For example, the first surface 26 ofthe septum 24 may be concave such that the infusion lumen 20 may have agenerally elliptical or oval shape, while the second surface 28 of theseptum 24 may be convex such that the aspiration lumen 22 may have agenerally crescent shape. In other embodiments, the curvature of theseptum 24 may be reversed, in which case the shapes of the infusionlumen 20 and the aspiration lumen 22 may also be reversed. In yet otherembodiments, the septum 24 may be planar, with opposing flat surfaces.

FIG. 13 illustrates exemplary flow paths of an infusion fluid and aneffluent at the distal end region of the catheter 10 shown in FIG. 11. Apressurized infusion fluid (e.g., saline, Rotoglide, etc.), from aninfusion fluid source (e.g., saline bag, etc.) in fluid communicationwith the infusion lumen 20, may pass through the infusion lumen 20 andbe in direct contact with the drive shaft 30. In some instances, theinfusion fluid may penetrate between adjacent coils of the drive shaft30 such that infusion fluid is located within the lumen of the driveshaft 30, such as between the outer surface of the guide wire liner 40and the inner surface of the drive shaft 30, or between the outersurface of a guide wire and the inner surface of the drive shaft 30(when no guide wire liner 40 is present), as well as along an exteriorof the drive shaft 30 (i.e., between the outer surface of the driveshaft 30 and the inner surface of the infusion lumen 20. In someinstances, the infusion fluid may provide one or more fluid bearingsbetween components of the catheter 10. The fluid bearings may be fluiddynamic bearings or hydrostatic bearings, for example.

The pressurized infusion fluid through the infusion lumen 20 interposedbetween the drive shaft 30 and the catheter body 16 may form a shaftfluid bearing between the drive shaft 30 and the catheter body 16 (i.e.,between the outer surface of the drive shaft 30 and the inner surface ofthe infusion lumen 20). The shaft fluid bearing may extend from thecatheter proximal portion near the manifold 12 to the catheter distalportion near the distal end of the drive shaft 30. For example, theshaft fluid bearing may extend along the length of the drive shaft 30.

The pressurized infusion fluid through the infusion lumen 20 interposedbetween the guide wire liner 40 or a guide wire in the guide wire lumen42 and the drive shaft 30 may form a guide wire fluid bearing betweenthe outer surface of the guide wire liner 40 or a guide wire and theinner surface of the drive shaft 30. The guide wire fluid bearing mayextend from the catheter proximal portion near the manifold 12 to thecatheter distal portion near the distal end of the drive shaft 30. Forexample, the guide wire fluid bearing may extend along the length of thedrive shaft 30.

The infusion fluid may exit the distal end region of the catheter 10 atone or more outflow ports. For example, as shown with the arrows in FIG.13, infusion fluid may pass through a clearance gap between the outersurface of the guide wire liner 40 and the inner surface of the borethrough the cutting member 60 and out the distal opening 44.Additionally or alternatively, infusion fluid may pass between theretaining ring 66 and the catheter body 16, between the retaining ring66 and the saddle 64, between the saddle 64 and the drive shaft 30and/or between the cutting member 60 (e.g., the neck 62) and the saddle64, and exit through a clearance gap between the cutting member 60 andthe saddle 64. The pressurized infusion fluid may form a fluid bearingbetween one or more of these structures, such as between one or more ofthe guide wire liner 40, guide wire, cutting member 60, saddle 64,retaining ring 66, drive shaft 30, and catheter body 16. For example,pressurized fluid through the infusion lumen 20 interposed between thecutting member 60 and the catheter body 16 (e.g., saddle 64) may form acutter fluid bearing between the cutting member 60 (e.g., neck 62) andthe catheter body 16 (e.g., saddle 64)), and/or pressurized fluidthrough the infusion lumen 20 interposed between the cutting member 60and the guide wire liner 40 or guide wire may form a cutter fluidbearing between the cutting member 60 and the guide wire liner 40 orguide wire extending through the bore of the cutting member 60.

In some instances, such as shown in FIGS. 11-13, the guide wire liner 40may include one or more, or a plurality of orifices 78 extending throughthe sidewall of the guidewire liner 40. Although three orifices 78 areshown, in other embodiments the guide wire liner 40 may include one,two, four, five, or more orifices arranged at any desired location alongthe guide wire liner 40. The orifice(s) may be provided so high pressurefluid (e.g., saline, lubricant, and/or medicament) within the infusionlumen 20 passes (e.g., weeps, oozes, drips, sprays, bleeds, etc.)through the orifice 78 to continually fill the lumen of the guide wireliner 40 with saline and/or lubricant, such as Rotoglide. Arrows shownin FIG. 13 illustrate infusion fluid passing through the orifices 78into the guide wire lumen 42 defined by the guide wire liner 40.Infusion fluid passing into the lumen of the guide wire liner 40 mayhelp lubricate the guide wire extending therethrough, for example. Oneor more of the orifices 78 may optionally be located near a distalportion of the catheter 10 (e.g., distal to the drive shaft 30 and/orwithin the bore of the cutting member 60).

Furthermore, the pressurized infusion fluid may provide a fluid barrierto prevent ingress of effluent, including particulates such as fibrin,from entering the distal end region of the catheter 10 through thedistal opening 44, between the outer surface of the guide wire liner 40and the inner surface of the bore through the cutting member 60, betweenthe cutting member 60 (e.g., the neck 62) and the saddle 64 or otherclearance gap between one or more of the guide wire liner 40, guidewire, cutting member 60, saddle 64, retaining ring 66, drive shaft 30,and catheter body 16. In other words, the pressure gradient between thepressurized infusion fluid within the distal end region of the catheter10 and the pressure within the body lumen may permit infusion fluid toexit through one or more of these pathways, while preventing effluent toenter the distal end region of the catheter 10 through one or more ofthese pathways.

Also shown in FIG. 13, a vacuum may be drawn through the aspirationlumen 22 via an aspiration source (e.g., pump) in communication with theaspiration lumen 22 to draw effluent (e.g., infusion fluid and entrainedparticulates) into the aspiration lumen 22 through the aspiration orinflow port 74. The effluent is isolated from the drive shaft 30 via theseptum 24. Therefore, the drive shaft 30 may be continuously coveredwith the infusion fluid, while not being fouled with particulates fromthe effluent.

An alternative distal end region of the catheter 10 is illustrated atFIGS. 14 and 15. The distal end region shown in FIGS. 14 and 15 may besimilar to the distal end region of the catheter 10 shown in FIGS. 10and 11 in many respects, with the exception of features noted below. Forinstance, the cutting member 60 may be rotatably coupled to the catheterbody 16 via a coupling assembly provided at the distal end region of theelongate shaft 14 to permit rotation between the cutting member 60/driveshaft 30 and the catheter body 16. For example, the coupling assemblymay include a saddle 64 at the distal end of the catheter body 16 and aretaining ring 66 secured to the drive shaft 30. Additionally, thecutting member 60 may include a distal opening 44 aligned with the guidewire lumen 42 to permit a guide wire to pass therethrough into the guidewire lumen 42. The guide wire liner 40, if present, may extend throughthe drive shaft 30 to define the guide wire lumen 42. The guide wireliner 40 may extend distal of the distal end of the drive shaft 30 intothe bore of the cutting member 60 to form an interface between thecutting member 60 and a guide wire extending through the guide wirelumen 42. The bore of the cutting member 60 may have a diameter slightlylarger than the outer diameter of the guide wire liner 40 to provide aclearance for infusion fluid to pass therebetween to lubricate the guidewire, as will be further discussed herein. The guide wire liner 40 mayremain stationary as the cutting member 60 is rotated. Thus, the cuttingmember 60 is rotatable relative to the guide wire liner 40 duringoperation, such that the guide wire is isolated from direct contact withthe rotating cutting member 60 except at the distal opening 44 of thecutting member 60. Further discussion of the similar features, and theirinteraction with other components has been described above, and thuswill not be repeated.

The distal end region of the catheter 10 shown in FIGS. 14 and 15 mayinclude a rotatable cutting member 60 having a distal cutter 60 a and aproximal cutter 60 b. Both the distal cutter 60 a and the proximalcutter 60 b may be rotated through rotation of the drive shaft 30. Thedistal cutter 60 a may include one or more flutes having a cutting edgefor removing occlusive material from a body lumen. In other instances,the distal cutter 60 a may be a burr having an abrasive surface, such asa diamond coated abrasive surface, or the distal cutter 60 a may be ofanother construction for abrading or cutting occlusive material. Theproximal cutter 60 b may be an expandable cutter including one or moreexpandable blades, or the proximal cutter 60 b may be a morcellator ormacerator for morcellating or macerating excised tissue, for example. Insome instances, the proximal cutter 60 b may have a first cuttingdiameter when the drive shaft 30 is rotated in a first rotationaldirection (e.g., clockwise) and a second cutting diameter when the driveshaft 30 is rotated in an opposite, second rotational direction (e.g.,counter-clockwise. The first cutting diameter may be different than thesecond cutting diameter, for example, the first cutting diameter may beless than the second cutting diameter. For instances, the blades of theproximal cutter 60 b may expand to the second cutting diameter or beyondfrom the first cutting diameter when the drive shaft 30 is rotated inthe second rotational direction.

Similar to the embodiment discussed above, as shown in FIG. 16, theinflow port 74 may open into the aspiration lumen 22 through a sidewallof the catheter body 16. The septum 24 may isolate the drive shaft 30,extending through the infusion lumen 20 from effluent passing into theaspiration lumen 22. Furthermore, FIG. 16 illustrates that within thedistal end region, the septum 24 may have a bowed or arcuateconfiguration such that one of the first and second surfaces 26, 28 ofthe septum 24 is convex while the other of the first and second surfaces26, 28 of the septum 24 is concave. For example, the first surface 26 ofthe septum 24 may be concave such that the infusion lumen 20 may have agenerally elliptical or oval shape, while the second surface 28 of theseptum 24 may be convex such that the aspiration lumen 22 may have agenerally crescent shape. In other embodiments, the curvature of theseptum 24 may be reversed, in which case the shapes of the infusionlumen 20 and the aspiration lumen 22 may also be reversed. In yet otherembodiments, the septum 24 may be planar, with opposing flat surfaces.

The pressurized infusion fluid through the infusion lumen 20 interposedbetween the drive shaft 30 and the catheter body 16 may form a shaftfluid bearing between the drive shaft 30 and the catheter body 16 (i.e.,between the outer surface of the drive shaft 30 and the inner surface ofthe infusion lumen 20). The shaft fluid bearing may extend from thecatheter proximal portion near the manifold 12 to the catheter distalportion near the distal end of the drive shaft 30. For example, theshaft fluid bearing may extend along the length of the drive shaft 30.

The pressurized infusion fluid through the infusion lumen 20 interposedbetween the guide wire liner 40 or a guide wire in the guide wire lumen42 and the drive shaft 30 may form a guide wire fluid bearing betweenthe outer surface of the guide wire liner 40 or a guide wire and theinner surface of the drive shaft 30. The guide wire fluid bearing mayextend from the catheter proximal portion near the manifold 12 to thecatheter distal portion near the distal end of the drive shaft 30. Forexample, the guide wire fluid bearing may extend along the length of thedrive shaft 30.

The infusion fluid may exit the distal end region of the catheter 10 atone or more outflow ports. For example, as shown with the arrows in FIG.17, infusion fluid may pass through a clearance gap between the outersurface of the guide wire liner 40 and the inner surface of the borethrough the cutting member 60 and out the distal opening 44.Additionally or alternatively, infusion fluid may pass between theretaining ring 66 and the catheter body 16, between the retaining ring66 and the saddle 64, between the saddle 64 and the drive shaft 30and/or between the cutting member 60 (e.g., the neck 62) and the saddle64, and exit through a clearance gap between the cutting member 60 andthe saddle 64. In some instances infusion fluid may also exit throughgaps in the proximal, expandable cutter 60 b. The pressurized infusionfluid may form a fluid bearing between one or more of these structures,such as between one or more of the guide wire liner 40, guide wire,cutting member 60, saddle 64, retaining ring 66, drive shaft 30, andcatheter body 16. For example, pressurized fluid through the infusionlumen 20 interposed between the cutting member 60 and the catheter body16 (e.g., saddle 64) may form a cutter fluid bearing between the cuttingmember 60 (e.g., neck 62) and the catheter body 16 (e.g., saddle 64),and/or pressurized fluid through the infusion lumen 20 interposedbetween the cutting member 60 and the guide wire liner 40 or guide wiremay form a cutter fluid bearing between the cutting member 60 and theguide wire liner 40 or guide wire extending through the bore of thecutting member 60.

In some instances, such as shown in FIGS. 15-17, the guide wire liner 40may include one or more, or a plurality of orifices 78 extending throughthe sidewall of the guidewire liner 40. Although three orifices 78 areshown, in other embodiments the guide wire liner 40 may include one,two, four, five, or more orifices arranged at any desired location alongthe guide wire liner 40. The orifice(s) may be provided so high pressurefluid (e.g., saline, lubricant, and/or medicament) within the infusionlumen 20 passes (e.g., weeps, oozes, drips, sprays, bleeds, etc.)through the orifice 78 to continually fill the lumen of the guide wireliner 40 with saline and/or lubricant, such as Rotoglide. Arrows shownin FIG. 17 illustrate infusion fluid passing through the orifices 78into the guide wire lumen 42 defined by the guide wire liner 40.Infusion fluid passing into the lumen of the guide wire liner 40 mayhelp lubricate the guide wire extending therethrough, for example. Oneor more of the orifices 78 may optionally be located near a distalportion of the catheter 10 (e.g., distal to the drive shaft 30 and/orwithin the bore of the cutting member 60).

Furthermore, the pressurized infusion fluid may provide a fluid barrierto prevent ingress of effluent, including particulates such as fibrin,from entering the distal end region of the catheter 10 through thedistal opening 44, between the outer surface of the guide wire liner 40and the inner surface of the bore through the cutting member 60, betweenthe cutting member 60 (e.g., the neck 62) and the saddle 64, betweenblades or other structure of the proximal, expandable cutter 60 b, orother clearance gap between one or more of the guide wire liner 40,guide wire, cutting member 60, saddle 64, retaining ring 66, drive shaft30, and catheter body 16. In other words, the pressure gradient betweenthe pressurized infusion fluid within the distal end region of thecatheter 10 and the pressure within the body lumen may permit infusionfluid to exit through one or more of these pathways, while preventingeffluent to enter the distal end region of the catheter 10 through oneor more of these pathways.

Also shown in FIG. 17, a vacuum may be drawn through the aspirationlumen 22 via an aspiration source (e.g., pump) in communication with theaspiration lumen 22 to draw effluent (e.g., infusion fluid and entrainedparticulates) into the aspiration lumen 22 through the aspiration orinflow port 74. The effluent is isolated from the drive shaft 30 via theseptum 24. Therefore, the drive shaft 30 may be continuously coveredwith the infusion fluid, while not being fouled with particulates fromthe effluent.

EXAMPLES

Example 1 can include subject matter, such as can include a matterelimination catheter comprising: a catheter body extending from acatheter proximal portion to a catheter distal portion, the catheterbody including: an infusion lumen an aspiration lumen fluidly isolatedfrom the infusion lumen, and a septum of the catheter body interposedbetween the infusion and aspiration lumens; a drive shaft within theinfusion lumen, the drive shaft configured to provide rotation near thecatheter distal portion; a guide wire lumen within the drive shaft; andwherein the infusion lumen, the drive shaft and the guide wire lumen arefluidly separated from the aspiration lumen with the septum.

Example 2 can include, or can optionally be combined with the subjectmatter of Example 1, to optionally include wherein the septum spans thecatheter body from a first portion of a catheter body side wall to asecond portion of the catheter body side wall.

Example 3 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 or 2 to optionallyinclude wherein the catheter body includes: at least one outflow portnear the catheter distal portion in communication with the infusionlumen near the catheter distal portion, and at least one inflow portnear the catheter distal portion in communication with the aspirationlumen near the catheter distal portion.

Example 4 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 3 to optionallyinclude an infusion fluid source in communication with the infusionlumen and configured to provide a source of pressurized infusion fluidthrough the infusion lumen and the outflow port; an aspiration source incommunication with the aspiration lumen and configured to aspirate theinfusion fluid and entrained matter through the inflow port at or nearthe catheter distal portion and the aspiration lumen; and wherein in anoperational mode the infusion fluid entrains matter from a vesselbetween the outflow port and the inflow port, and the entrained matterand infusion fluid are delivered to the catheter proximal portionthrough the aspiration lumen.

Example 5 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-4 optionally to includewherein in a pressurized configuration pressure of the infusion fluidwithin the infusion lumen is greater than pressure of the infusion fluidwith entrained matter, and the infusion fluid with entrained matter isdirected away from the drive shaft within the infusion lumen accordingto the pressure difference.

Example 6 can include, or can optionally be combined with the subjectmatter of Examples 1-5 to optionally include a guide wire liner withinthe guide wire lumen of the drive shaft, wherein the drive shaft isrotatable relative to the guide wire liner.

Example 7 can include, or can optionally be combined with the subjectmatter of Examples 1-6 to optionally include one or more fluid bearingsisolated from the aspiration lumen and generated with pressurizedinfusion fluid delivered through the infusion lumen.

Example 8 can include, or can optionally be combined with the subjectmatter of Examples 1-7 to optionally include wherein the one or morefluid bearings include one or more of fluid dynamic bearings orhydrostatic bearings.

Example 9 can include, or can optionally be combined with the subjectmatter of Examples 1-8 to optionally include at least one shaft fluidbearing interposed between the catheter body and the drive shaft in theinfusion lumen, and the at least one shaft fluid bearing is generatedwith pressurized infusion fluid delivered through the infusion lumen.

Example 10 can include, or can optionally be combined with the subjectmatter of Examples 1-9 to optionally include wherein the at least oneshaft fluid bearing extends from the catheter proximal portion to thecatheter distal portion.

Example 11 can include, or can optionally be combined with the subjectmatter of Examples 1-10 to optionally include wherein the at least oneshaft fluid bearing extends the length of the drive shaft.

Example 12 can include, or can optionally be combined with the subjectmatter of Examples 1-11 to optionally include at least one guide wirefluid bearing interposed between the drive shaft and at least one of aguide wire or a guide wire liner in the guide wire lumen, wherein the atleast one guide wire fluid bearing is generated with pressurizedinfusion fluid delivered through the infusion lumen and penetrating thedrive shaft.

Example 13 can include, or can optionally be combined with the subjectmatter of Examples 1-12 to optionally include wherein the drive shaft iscoupled to at least one rotatable cutter near the catheter distalportion, and the drive shaft and the at least one rotatable cutter arerotatable in a clockwise and/or a counter clock-wise direction relativeto the catheter body.

Example 14 can include, or can optionally be combined with the subjectmatter of Examples 1-13 to optionally include wherein at least onecutter fluid bearing is interposed between the rotatable cutter and thecatheter body, and the at least one cutter fluid bearing is formedbetween a cutter interface and a catheter body interface withpressurized infusion fluid delivered from the infusion lumen.

Example 15 can include, or can optionally be combined with the subjectmatter of Examples 1-14 to optionally include a catheter body extendingfrom a catheter proximal portion to a catheter distal portion, thecatheter body including: an infusion lumen in fluid communication withat least one outflow port near the catheter distal portion, anaspiration lumen isolated from the infusion lumen, and a septum of thecatheter body interposed between the infusion and aspiration lumens; adrive shaft within the infusion lumen, the drive shaft configured toprovide rotation near the catheter distal portion; and wherein in aninfusion configuration an infusion fluid is delivered through theinfusion lumen to the at least one outflow port: the drive shaft and aportion of the catheter body associated with the infusion lumen areconfigured to provide at least one shaft fluid bearing therebetween withthe infusion fluid, and wherein the at least one outflow port isconfigured to provide a fluid barrier with the infusion fluid to preventingress of infusion fluid with entrained matter into the infusion lumen.

Example 16 can include, or can optionally be combined with the subjectmatter of Examples 1-15 to optionally include wherein the infusionlumen, the drive shaft and a guide wire lumen within the drive shaft areseparated from the aspiration lumen with the septum.

Example 17 can include, or can optionally be combined with the subjectmatter of Examples 1-16 to optionally include wherein the septum spansthe catheter body from a first portion of a catheter body side wall to asecond portion of the catheter body side wall.

Example 18 can include, or can optionally be combined with the subjectmatter of Examples 1-17 to optionally include wherein the fluid barrierprevents ingress of the infusion fluid with entrained matter accordingto a first pressure of the infusion fluid within the infusion lumenbeing greater than a second pressure of the infusion fluid with theentrained matter.

Example 19 can include, or can optionally be combined with the subjectmatter of Examples 1-18 to optionally include wherein in the infusionconfiguration an interior surface of the drive shaft and at least one ofa guide wire or a guide wire liner within a guide wire lumen of thedrive shaft are configured to provide at least one guide wire fluidbearing with the infusion fluid.

Example 20 can include, or can optionally be combined with the subjectmatter of Examples 1-19 to optionally include wherein the infusion fluidpenetrates the drive shaft to provide the at least one guide wire fluidbearing.

Example 21 can include, or can optionally be combined with the subjectmatter of Examples 1-20 to optionally include wherein the at least oneshaft fluid bearing is isolated from the aspiration lumen by the fluidbarrier and the septum.

Example 22 can include, or can optionally be combined with the subjectmatter of Examples 1-20 to optionally include wherein the at least oneshaft fluid bearing extends from the catheter proximal portion to thecatheter distal portion.

Example 23 can include, or can optionally be combined with the subjectmatter of Examples 1-22 to optionally include wherein the at least oneshaft fluid bearing extends substantially the length of the drive shaft.

Example 24 can include, or can optionally be combined with the subjectmatter of Examples 1-23 to optionally include wherein the drive shaft iscoupled to at least one rotatable cutter near the catheter distalportion, and the drive shaft and the at least one rotatable cutter arerotatable in a clockwise and/or counter clockwise direction relative tothe catheter body.

Example 25 can include, or can optionally be combined with the subjectmatter of Examples 1-24 to optionally include wherein in the infusionconfiguration the at least one rotatable cutter and the catheter bodyare configured to provide at least one cutter fluid bearing therebetweenwith the infusion fluid.

Example 26 can include, or can optionally be combined with the subjectmatter of Examples 1-25 to optionally include a manifold coupled to thecatheter proximal portion, the manifold comprising an infusion portconfigured to deliver infusion fluid to the infusion lumen.

Example 27 can include, or can optionally be combined with the subjectmatter of Examples 1-26 to optionally include wherein the manifoldfurther comprises: a composite lumen, the composite lumen receiving aproximal portion of the drive shaft, and a seal, wherein the drive shaftand a guide wire lumen within the drive shaft extend through the seal.

Example 28 can include, or can optionally be combined with the subjectmatter of Examples 1-27 to optionally include wherein the manifoldfurther comprises a diversion sleeve positioned around the drive shaftand extending proximally relative to the infusion port.

Example 29 can include, or can optionally be combined with the subjectmatter of Examples 1-28 to optionally include wherein in the infusionconfiguration the infusion fluid is directed distally over an exteriorperimeter of the diversion sleeve, and at a distal end of the diversionsleeve a first portion of the infusion fluid flows distally through theinfusion lumen toward the catheter distal portion and a second portionof the infusion fluid flows proximally along an interior perimeter ofthe diversion sleeve, the first and second portions controlled by thedimensions between the interior perimeter of the diversion sleeve andthe drive shaft.

Example 30 can include, or can optionally be combined with the subjectmatter of Examples 1-29 to optionally include wherein the diversionsleeve and the drive shaft are configured to provide a second shaftfluid bearing therebetween with the second portion of the infusionfluid.

Example 31 can include, or can optionally be combined with the subjectmatter of Examples 1-30 to optionally include wherein the drive shaftand at least one of a guide wire or guide wire lumen are configured toprovide a guide wire fluid bearing with the first portion of theinfusion fluid.

Example 32 can include a method of using of a matter eliminationcatheter in accordance with the subject matter of Examples 1-31,including one or more of the following steps: A) aspirating in theaspiration lumen, B) infusing infusion fluid in the infusion lumen, theinfusion lumen including a drive shaft and a guide wire lumen separatedfrom the aspiration lumen, C) lubricating the drive shaft in theinfusion lumen and/or lubricate the guide wire in the infusionlumen/guide wire lumen, D) preventing ingress of infusion fluid withentrained matter into the infusion lumen with a fluid barrier, and E)optionally forming a fluid bearing for one or more of the drive shaft inthe infusion lumen with infusion fluid or for a guide wire configuredfor positioning within the drive shaft.

Each of these non-limiting examples can stand on its own, or can becombined in any permutation or combination with any one or more of theother examples.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments in which theinvention can be practiced. These embodiments are also referred toherein as “examples.” Such examples can include elements in addition tothose shown or described. However, the present inventors alsocontemplate examples in which only those elements shown or described areprovided. Moreover, the present inventors also contemplate examplesusing any combination or permutation of those elements shown ordescribed (or one or more aspects thereof), either with respect to aparticular example (or one or more aspects thereof), or with respect toother examples (or one or more aspects thereof) shown or describedherein.

Those skilled in the art will recognize that aspects of the presentdisclosure may be manifested in a variety of forms other than thespecific embodiments described and contemplated herein. Accordingly,departure in form and detail may be made without departing from thescope and spirit of the present disclosure as described in the appendedclaims.

What is claimed is:
 1. A matter elimination catheter, comprising: acatheter body extending from a catheter proximal portion to a catheterdistal portion, the catheter body including an infusion lumen; a driveshaft disposed within the infusion lumen, the drive shaft beingconfigured to provide rotation to at least one rotatable cutter coupledto the drive shaft near the catheter distal portion; and a guide wireliner extending through the drive shaft, the guide wire liner defining aguide wire lumen therein, wherein the drive shaft is rotatable relativeto the guide wire liner; wherein pressurized infusion fluid deliveredthrough the infusion lumen and flowing distally between an outer surfaceof the guide wire liner and an inner surface of the infusion lumen formsa first guide wire fluid bearing interposed between an outer surface ofthe guide wire liner and an inner surface of the at least one rotatablecutter, wherein the first guide wire fluid bearing is generated withpressurized infusion fluid delivered through the infusion lumen andflowing distally between the outer surface of the guide wire liner andan inner surface of at least one rotatable cutter.
 2. The matterelimination catheter of claim 1, further comprising a pressurizedinfusion fluid source in fluid communication with the infusion lumen andconfigured to provide pressurized infusion fluid delivered to at leastone outflow port and delivered through at least one orifice extendingthrough a sidewall of the guide wire liner to form the first guide wirefluid bearing.
 3. The matter elimination catheter of claim 2, whereinthe catheter body further comprises an aspiration lumen fluidly isolatedfrom the infusion lumen.
 4. The matter elimination catheter of claim 3,wherein the aspiration lumen terminates with least one inflow port nearthe catheter distal portion.
 5. The matter elimination catheter of claim4, wherein the infusion lumen terminates at a point distal of adistalmost at least one inflow port.
 6. The matter elimination catheterof claim 3, further comprising an aspiration source in communicationwith the aspiration lumen and configured to draw effluent includinginfusion fluid and entrained particulates into and through the infusionlumen.
 7. The matter elimination catheter of claim 6, wherein thepressurized infusion fluid source and the aspiration source areconfigured to maintain an isovolumetric treatment site.
 8. The matterelimination catheter of claim 6, wherein the pressurized infusion fluidsource and the aspiration source are configured to maintain a pressuredifferential between the pressurized infusion fluid within the infusionlumen and aspirated infusion fluid and entrained particulates within theinfusion lumen.
 9. The matter elimination catheter of claim 6, whereinthe pressurized infusion fluid source is configured to deliver infusionfluid through the at least one outflow port sufficient to provide afluid barrier at the at least one outflow port that prevents ingress ofparticulates.
 10. A matter elimination catheter, comprising: a catheterbody extending from a catheter proximal portion to a catheter distalportion, the catheter body including an infusion lumen and an aspirationlumen; and a drive shaft disposed within the infusion lumen, the driveshaft being configured to provide rotation to at least one rotatablecutter coupled to the drive shaft near the catheter distal portion; anda guide wire liner extending through the drive shaft, the guide wireliner defining a guide wire lumen therein, wherein the drive shaft isrotatable relative to the guide wire liner; wherein pressurized infusionfluid delivered through the infusion lumen and flowing distally betweenan outer surface of the guide wire liner and an inner surface of theinfusion lumen forms a first guide wire fluid bearing interposed betweenan outer surface of the guide wire liner and an inner surface of the atleast one rotatable cutter, wherein the first guide wire fluid bearingis generated with pressurized infusion fluid delivered through theinfusion lumen and flowing distally between the outer surface of theguide wire liner and the inner surface of the at least one rotatablecutter, wherein the infusion lumen is in fluid communication with apressurized infusion fluid source, wherein the aspiration lumen is influid communication with an aspiration source configured to draweffluent including infusion fluid and entrained particulates into andthrough the aspiration lumen.
 11. The matter elimination catheter ofclaim 10, wherein the pressurized infusion fluid source and theaspiration source are configured to maintain an isovolumetric treatmentsite.
 12. The matter elimination catheter of claim 10, wherein theaspiration lumen terminates with at least one inflow port near thecatheter distal portion.
 13. The matter elimination catheter of claim12, wherein the infusion lumen terminates at a point distal of adistalmost at least one inflow port.
 14. The matter elimination catheterof claim 10, wherein the pressurized infusion fluid source is configuredto deliver infusion fluid through at least one outflow port sufficientto provide a fluid barrier at the at least one outflow port thatprevents ingress of particulates.
 15. A method of using of a matterelimination catheter having catheter body comprising: an infusion lumenin fluid communication with a pressurized infusion fluid source; anaspiration lumen in fluid communication with an aspiration sourceconfigured to draw effluent including infusion fluid and entrainedparticulates into and through the aspiration lumen, wherein the infusionlumen and the aspiration lumen are separated by a fluid barrier; a driveshaft disposed within the infusion lumen, the drive shaft beingconfigured to provide rotation to at least one rotatable cutter; and aguide wire liner defining a guide wire lumen, wherein pressurizedinfusion fluid delivered to at least one outflow port and through atleast one orifice extending through a side wall of the guide wire linerand flowing distally between an outer surface of the guide wire linerand an inner surface of the infusion lumen forms a first guide wirefluid bearing between the guide wire liner and the at least onerotatable cutter, the method comprising: rotating the drive shaft andthe at least one rotatable cutter; infusing pressurized infusion fluidthrough the infusion lumen, through at least one orifice extendingthrough a side wall of the guide wire liner, between the guide wireliner and the at least one rotatable cutter, and through at least oneoutflow port, lubricating the drive shaft within the infusion lumen;lubricating the rotatable cutter about the guide wire liner; preventingingress of infusion fluid with entrained matter into the infusion lumenwith a fluid barrier; and aspirating in the aspiration lumen.
 16. Themethod of claim 15, wherein the pressurized infusion fluid source andthe aspiration source are configured to maintain a pressure differentialbetween the pressurized infusion fluid within the infusion lumen andaspirated infusion fluid and entrained particulates within the infusionlumen.
 17. The method of claim 15, wherein the infusion lumen terminatesat a point distal of a distalmost at least one inflow port.
 18. Themethod of claim 15, wherein infusing pressurized infusion fluid throughthe infusion lumen further lubricates a guide wire positioned within thedrive shaft.
 19. The method of claim 15, further comprising: maintainingan isovolumetric treatment site between the at least one outflow portand an inflow port in fluid communication with the aspiration lumen. 20.The method of claim 15, wherein the at least one rotatable cutter isrotatable relative to the guide wire liner.